Method for steam sterilization of medical articles

Abstract

The invention relates to a method for thermal sterilization in particular of a container filled with medical material or product, the method comprising a sterilization method step in which a thermal sterilization in particular is carried out of a container filled with medical material or product in the presence of a sterilization atmosphere, containing steam, at temperatures of at least 100° C. and at increased pressure, wherein the sterilization method step comprises at least a first method stage and a second method stage, following the first method stage, with first and second method stages being carried out at different pressures with respect to one another, the pressure in the second method stage being increased relative to the pressure in the first method stage.

The invention claimed is: 
     
       1. A method for thermal sterilization of a medical container filled with a liquid or flowable medical material or product, wherein the method comprises a sterilization step where a container filled with a medical material or product is subjected to a thermal sterilization in the presence of a sterilization atmosphere containing steam, at temperatures of at least 100° C. and at an increased pressure,
 wherein the sterilization step is preceded by a heating step; 
 wherein the sterilization step is carried out in a relative pressure range of between 0.05 and 10 bar or in an absolute pressure range of between 1.05 bar and 11 bar; 
 wherein the sterilization step comprises at least a first stage and a second stage following the first stage, 
 wherein the first and second stages are each carried out at different pressures with respect to one another, wherein the pressure in the second stage is increased relative to the pressure in the first stage, 
 wherein the relative pressure increase from the first to the second stage of the sterilization step is at least 0.01 bar and 
 wherein the pressure increase from the first to the second stage of the sterilization step is effected by introducing air; and 
 wherein the sterilization is followed by a cooling step wherein during the cooling step, a supporting pressure is applied at least temporarily, such that the pressure present in the medical container filled with medical material or product is counteracted. 
 
     
     
       2. The method according to  claim 1 , wherein the sterilization step is carried out in the presence of a steam/gas mixture. 
     
     
       3. The method according to  claim 2 , wherein the steam/gas mixture comprises a mixture of steam with at least one of nitrogen, oxygen and inert gases. 
     
     
       4. The method according to  claim 1 , wherein the method is carried out in a closed sterilization apparatus. 
     
     
       5. The method according to  claim 1 , wherein the method is carried out in an autoclaving apparatus. 
     
     
       6. The method according to  claim 1 , wherein the sterilization atmosphere is produced by injecting steam/compressed air mixtures into the sterilization apparatus. 
     
     
       7. The method according to  claim 6 , wherein the steam is produced from distilled or demineralized water and wherein the compressed air is produced from sterile air. 
     
     
       8. The method according to  claim 1 , wherein the sterilization step is carried out in a temperature range of between 100 and 180° C. 
     
     
       9. The method according to  claim 1 , wherein the sterilization step is carried out in a temperature between 110 and 130° C. 
     
     
       10. The method according to  claim 1 , wherein the sterilization step is carried out in a relative pressure range of between 0.1 and 4 bar or in an absolute pressure range of between 1.1 and 5 bar. 
     
     
       11. The method according to  claim 1 , wherein the sterilization step comprises 2 to 10 stages, wherein at least 2 stages are carried out at different pressures, with the pressure being increased in a subsequent stage compared to the pressure in a preceding stage. 
     
     
       12. The method according to  claim 1 , wherein, at least during the sterilization step, the method is controlled and monitored by measuring and regulating at least one of pressure and temperature of the sterilization atmosphere and optionally the temperature of at least one reference sample situated in the sterilization apparatus. 
     
     
       13. The method according to  claim 1 , wherein, at least during the sterilization step, at least one of pressure and temperature of the sterilization atmosphere and optionally the temperature of at least one reference sample situated in the sterilization apparatus are determined and set to predetermined values. 
     
     
       14. The method according to  claim 13 , wherein the pressure and temperature data are used to monitor and to control at least the sterilization step. 
     
     
       15. The method according to  claim 1 , wherein, during the heating step, at least one of pressure and temperature of the atmosphere within the sterilization apparatus is modified. 
     
     
       16. The method according to  claim 1 , wherein, during the cooling step, at least one of pressure and temperature of the atmosphere within the sterilization apparatus is modified. 
     
     
       17. The method according to  claim 1 , wherein the medical material or product is a medicine, a pharmaceutical or medical product. 
     
     
       18. The method according to  claim 1 , wherein the medical material or product is a catheter lubricant. 
     
     
       19. The method according to  claim 1 , wherein the container is an ampoule, a tube or a medical instrument. 
     
     
       20. The method according to  claim 1 , wherein the container is a catheter or a syringe.